Metronidazole 500mg/100ml Inj,100ml

Manufacturer SUN PHARMACEUTICALS Active Ingredient Metronidazole Injection(met roe NYE da zole) Pronunciation met roe NYE da zole
WARNING: Metronidazole has been shown to cause cancer in mice and rats with long-term use. Talk with the doctor.The doctor has given you this drug for a certain health problem. Do not use this drug for other health problems. @ COMMON USES: It is used to treat infections.It is used to prevent infections during bowel surgery.It may be given to you for other reasons. Talk with the doctor.
đŸˇī¸
Drug Class
Antibiotic, Antiprotozoal
đŸ§Ŧ
Pharmacologic Class
Nitroimidazole
🤰
Pregnancy Category
Category B
✅
FDA Approved
Jun 1963
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Metronidazole is an antibiotic and anti-parasitic medication given through an IV. It works by stopping the growth of certain bacteria and parasites that cause infections in different parts of the body, such as the abdomen, skin, joints, and reproductive organs.
📋

How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is administered as an infusion into a vein over a period of time.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on what to do next.
💡

Lifestyle & Tips

  • **Avoid alcohol completely** during treatment and for at least 3 days after stopping metronidazole. Drinking alcohol can cause severe nausea, vomiting, flushing, headache, and stomach cramps (a disulfiram-like reaction). This includes alcohol in medications, mouthwashes, and other products.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Report any unusual numbness, tingling, pain, or weakness in your hands or feet to your doctor immediately.
  • Report any signs of confusion, seizures, or vision changes to your doctor immediately.
  • This medication may cause your urine to turn a dark or reddish-brown color, which is harmless.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 500 mg IV every 8 hours
Dose Range: 500 - 1000 mg

Condition-Specific Dosing:

Anaerobic Infections (initial dose): 15 mg/kg IV infused over 1 hour, then 7.5 mg/kg IV every 6 hours or 500 mg IV every 8 hours.
Surgical Prophylaxis: 15 mg/kg IV infused over 30-60 minutes, completed 1 hour before surgery. Then 7.5 mg/kg IV at 6 and 12 hours after initial dose.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established for routine use; consult infectious disease specialist. Dosing typically 7.5-15 mg/kg/day divided every 12-24 hours.
Infant: 7.5 mg/kg IV every 8 hours (max 4 g/day).
Child: 7.5 mg/kg IV every 8 hours (max 4 g/day).
Adolescent: 500 mg IV every 8 hours (max 4 g/day).
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed for single dose. For prolonged therapy, consider reducing dose by 50% for CrCl < 10 mL/min.
Dialysis: Metronidazole and its metabolites are removed by hemodialysis. Administer dose after hemodialysis on dialysis days. No adjustment needed for peritoneal dialysis.

Hepatic Impairment:

Mild: No adjustment.
Moderate: Reduce dose by 50% for patients with severe hepatic impairment (Child-Pugh C).
Severe: Reduce dose by 50% for patients with severe hepatic impairment (Child-Pugh C).
Confidence: Medium

Pharmacology

đŸ”Ŧ

Mechanism of Action

Metronidazole is a nitroimidazole antimicrobial. It enters bacterial and protozoal cells, where its nitro group is reduced by electron transport proteins to highly reactive nitro radical anions. These reactive intermediates damage DNA and other macromolecules, leading to cell death. This reduction process occurs only in anaerobic or microaerophilic conditions, explaining its selective activity against anaerobes and certain protozoa.
📊

Pharmacokinetics

Absorption:

Bioavailability: Not applicable for IV formulation (100% for IV)
Tmax: End of infusion (for IV)
FoodEffect: Not applicable for IV formulation

Distribution:

Vd: 0.51-1.1 L/kg
ProteinBinding: Less than 20%
CnssPenetration: Yes

Elimination:

HalfLife: 6-11 hours (parent drug), 9.5-18 hours (hydroxymetabolite)
Clearance: Not available (variable)
ExcretionRoute: Renal (60-80%), Fecal (6-15%)
Unchanged: Approximately 20% (renal)
âąī¸

Pharmacodynamics

OnsetOfAction: Rapid (within minutes of IV infusion)
PeakEffect: End of infusion
DurationOfAction: Approximately 8 hours (based on dosing frequency)
Confidence: Medium

Safety & Warnings

âš ī¸

BLACK BOX WARNING

Metronidazole has been shown to be carcinogenic in mice and rats. Tumors of the lung and liver were increased in mice and mammary tumors and hepatic nodules were increased in rats. These findings have been observed in studies with chronic (lifetime) oral dosing. It is unknown whether these findings are relevant to humans. Therefore, metronidazole should be used only when clearly indicated.
âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Redness or white patches in the mouth or throat
Vaginal itching or discharge
Abnormal or rapid heartbeat
Painful urination or blood in the urine
Frequent urination
Pelvic pain
Ringing in the ears, hearing loss, or other changes in hearing
Nervous system problems, including:
+ Burning, numbness, or tingling sensations
+ Changes in balance or vision
+ Dizziness or fainting
+ Headache
+ Insomnia
+ Seizures
+ Speech difficulties
Mood changes, such as:
+ Confusion
+ Depression
+ Irritability
+ Fatigue
+ Weakness
Symptoms of aseptic meningitis, including:
+ Headache
+ Fever
+ Chills
+ Nausea or vomiting
+ Stiff neck
+ Rash
+ Sensitivity to light
+ Drowsiness
+ Confusion
Signs of infection, such as:
+ Fever
+ Chills
+ Sore throat
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may affect internal organs
+ Symptoms include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects, contact your doctor if they bother you or do not resolve on their own:

Gastrointestinal symptoms, such as:
+ Constipation
+ Diarrhea
+ Stomach pain
+ Nausea or vomiting
+ Decreased appetite
Stomach cramps
Metallic taste
Headache
Joint pain
Decreased libido
Irritation at the injection site

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe nausea or vomiting
  • Severe headache
  • Dizziness or lightheadedness
  • Numbness, tingling, or pain in hands or feet (peripheral neuropathy)
  • Seizures
  • Confusion or hallucinations
  • Vision changes (e.g., double vision, blurred vision)
  • Rash, itching, or hives
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Severe diarrhea (especially if watery or bloody)
  • Unusual bleeding or bruising
  • Yellowing of the skin or eyes (jaundice)
📋

Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have Cockayne syndrome, as some individuals with this condition have experienced liver problems while taking this medication. In some cases, these liver issues have been severe, persistent, or even fatal.
If you have taken disulfiram within the past 14 days.
If you are less than 12 weeks pregnant, as this medication is not intended for use during this period.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
âš ī¸

Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor will also instruct you to have regular blood tests, so be sure to follow their guidance and discuss any concerns with them.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug. If you are undergoing dialysis, consult with your doctor to discuss any necessary precautions.

To minimize potential interactions, you may need to avoid consuming alcohol or products containing alcohol or propylene glycol during treatment with this medication and for at least 72 hours after your last dose. Examples of products that may contain alcohol or propylene glycol include some cough syrups. Consuming these substances may cause adverse effects such as stomach cramps, nausea, vomiting, headaches, and flushing. Consult with your doctor to determine if you need to avoid alcohol or products containing alcohol or propylene glycol.

Do not take this medication for longer than prescribed, as this may increase the risk of a second infection. If you are following a low-sodium or sodium-free diet, consult with your doctor, as some formulations of this medication may contain sodium.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks of this medication with their doctor to ensure informed decision-making.
🆘

Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Ataxia (loss of coordination)
  • Disorientation
  • Seizures
  • Peripheral neuropathy (with prolonged high doses)

What to Do:

There is no specific antidote for metronidazole overdose. Treatment is symptomatic and supportive. Gastric lavage may be considered if ingestion was recent. Hemodialysis can remove metronidazole and its metabolites. Call 1-800-222-1222 (Poison Control Center) immediately for advice.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Alcohol (including propylene glycol-containing products) - disulfiram-like reaction
  • Disulfiram (within 2 weeks) - psychotic reactions
🔴

Major Interactions

  • Warfarin and other oral anticoagulants (increased anticoagulant effect)
  • Lithium (increased lithium levels and toxicity)
  • Busulfan (increased busulfan toxicity)
  • Phenytoin, Phenobarbital (decreased metronidazole levels, increased phenytoin levels)
  • Cimetidine (increased metronidazole levels)
🟡

Moderate Interactions

  • Fluorouracil (increased fluorouracil toxicity)
  • Cyclosporine (increased cyclosporine levels)
  • Tacrolimus (increased tacrolimus levels)
  • Oral contraceptives (potential for reduced efficacy, though clinical significance debated)
đŸŸĸ

Minor Interactions

  • Cholestyramine (decreased metronidazole absorption if oral formulation used)

Monitoring

đŸ”Ŧ

Baseline Monitoring

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess baseline hepatic function, especially in patients with known or suspected liver impairment, as metronidazole is metabolized in the liver.

Timing: Prior to initiation of therapy

Renal function (CrCl, BUN, creatinine)

Rationale: To assess baseline renal function, though dose adjustment is generally not needed for mild-moderate impairment, it's important for severe impairment and dialysis patients.

Timing: Prior to initiation of therapy

Complete Blood Count (CBC) with differential

Rationale: To establish baseline hematologic status, as metronidazole can rarely cause neutropenia or leukopenia.

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Signs and symptoms of peripheral neuropathy (numbness, tingling, weakness)

Frequency: Daily, especially with prolonged therapy (>10 days)

Target: Absence of symptoms

Action Threshold: If symptoms develop, consider discontinuing metronidazole or reducing dose.

Signs and symptoms of CNS toxicity (seizures, encephalopathy, aseptic meningitis)

Frequency: Daily

Target: Absence of symptoms

Action Threshold: If symptoms develop, discontinue metronidazole immediately.

INR (for patients on warfarin)

Frequency: More frequently (e.g., daily to every few days) during co-administration and for several days after metronidazole discontinuation.

Target: Therapeutic range for indication

Action Threshold: Adjust warfarin dose to maintain target INR; anticipate significant increase in INR.

Lithium levels (for patients on lithium)

Frequency: More frequently (e.g., 2-3 times per week) during co-administration.

Target: Therapeutic range for indication

Action Threshold: Adjust lithium dose to maintain target levels; monitor for signs of lithium toxicity.

CBC with differential

Frequency: Periodically (e.g., weekly) during prolonged therapy

Target: Within normal limits

Action Threshold: If significant neutropenia or leukopenia develops, consider discontinuing metronidazole.

đŸ‘ī¸

Symptom Monitoring

  • Nausea
  • Vomiting
  • Diarrhea
  • Metallic taste
  • Headache
  • Dizziness
  • Peripheral neuropathy (numbness, tingling, weakness)
  • Seizures
  • Encephalopathy
  • Aseptic meningitis
  • Rash
  • Darkening of urine

Special Patient Groups

🤰

Pregnancy

Metronidazole crosses the placenta. While animal studies show some evidence of carcinogenicity, human data from controlled studies and meta-analyses have not shown an increased risk of birth defects or other adverse outcomes when used during the second and third trimesters. Use in the first trimester is generally avoided if possible, but may be considered if clearly needed and benefits outweigh risks.

Trimester-Specific Risks:

First Trimester: Avoid if possible; use only if clearly indicated and no safer alternative exists. Some older studies suggested a possible association with cleft lip/palate, but more recent and larger studies have not confirmed this.
Second Trimester: Generally considered safe and compatible with pregnancy.
Third Trimester: Generally considered safe and compatible with pregnancy.
🤱

Lactation

Metronidazole is excreted into breast milk in concentrations similar to maternal plasma. Due to the potential for serious adverse reactions, including carcinogenicity (based on animal data), in the breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If a single high dose is given, breastfeeding can be interrupted for 12-24 hours.

Infant Risk: L3 (Moderate risk) - Potential for gastrointestinal upset (diarrhea, candidiasis), metallic taste, and theoretical risk of carcinogenicity (based on animal data). Monitor infant for adverse effects.
đŸ‘ļ

Pediatric Use

Metronidazole is used in pediatric patients for various anaerobic and protozoal infections. Dosing is weight-based. Neonates and infants may have reduced clearance, requiring careful monitoring and dose adjustment. Safety and efficacy in very low birth weight infants have not been fully established.

👴

Geriatric Use

No specific dose adjustment is generally required based solely on age. However, elderly patients are more likely to have decreased hepatic function, which may necessitate dose reduction in severe impairment. Monitor for adverse effects, especially neurological ones, as elderly patients may be more susceptible.

Clinical Information

💎

Clinical Pearls

  • Metronidazole is a potent anaerobic and antiprotozoal agent, but it has no activity against aerobic bacteria.
  • The disulfiram-like reaction with alcohol is severe and patients must be counselled rigorously to avoid all alcohol-containing products during and for at least 3 days after therapy.
  • Prolonged or high-dose therapy can lead to peripheral neuropathy or CNS toxicity (e.g., seizures, encephalopathy). Monitor for these symptoms and discontinue if they occur.
  • Metronidazole can significantly potentiate the effect of warfarin, requiring frequent INR monitoring and dose adjustments.
  • IV metronidazole should be infused slowly over 30-60 minutes to minimize infusion-related reactions.
  • Urine discoloration (darkening) is a common and harmless side effect.
🔄

Alternative Therapies

  • Clindamycin (for anaerobic infections, but less effective against some protozoa)
  • Tigecycline (broad-spectrum, including anaerobes)
  • Carbapenems (e.g., Imipenem, Meropenem, Ertapenem - broad-spectrum, including anaerobes)
  • Tinidazole (another nitroimidazole, similar spectrum, longer half-life)
  • Oral Vancomycin or Fidaxomicin (for C. difficile infection, where metronidazole is also used)
💰

Cost & Coverage

Average Cost: Varies widely by supplier and contract per 100ml IV bag
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
📚

General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide details about the medication taken, the amount, and the time it occurred.